FDA Medical Device Recalls (openFDA)
Philips North America Llc: DigitalDiagnost C50 1.1
- Recall number
- Z-1563-2022
- Recalling firm
- Philips North America Llc
- Product
- DigitalDiagnost C50 1.1
- Status
- Open, Classified
- Initiated
- 2022-02-25
- Posted
- 2022-09-01
- Terminated
- not on file
- Reason
- Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
- Root cause
- Software Design Change
- Action
- Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377.
- Quantity
- 11 systems (updated 1/3/2023)
- Distribution
- Nationwide Distribution including Puerto Rico
- Lot, serial or model codes
- Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
- 510(k) numbers
- ["K163410","K201725"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28